Company Summary:
Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF15. For more information about Leap Therapeutics, please visit http://www.leaptx.com.
General Responsibilities:
The successful candidate will support the continued development and manufacturing of Leap products in clinical development. This role will be responsible for leading the GMP QA strategy for both early and late-stage clinical studies. He/She will be responsible for continuous improvement initiatives to support CMC activities including manufacturing, testing, vendor oversight and defining GMP policies and procedures.
The role is within a highly motivated team and provides opportunities to cross train and enhance skills in the GxP areas. The successful candidate will be a key contributor to the departmental objectives and support the management of key corporate milestones.
Specific responsibilities include:
Leadership and strategy
- Partner effectively with other functional areas to develop and maintain a meaningful and robust Patient First quality culture for Leap developed products.
- Champion and advocate for Leap’s Quality Management System (QMS) with cross-functional teams.
- Influence the overall CMC development strategy throughout the product lifecycle based on current industry standards and health authority guidance.
CMC QA Oversight
- Lead and optimize GMP Quality Assurance oversight appropriate with phase of drug development.
- Support programs teams to define and implement the overall CMC lifecycle strategy.
- Participate in selection of vendors and drive the qualification and quality management of vendors supporting CMC activities.
- Provide quality oversight to ensure that product characterization, product specifications, method validation, stability, and comparability assessments for technology transfers are in accordance with global regulatory requirements and internal procedures/policies.
- Perform batch record review, and disposition related activities for Drug Substance, Drug Product, Packaging, and Labeling runs for Leap managed products.
- Review and approve analytical method validations plans and final reports
- Perform review and approval of analytical testing data for Drug Substance and Drug Product.
- Provide QA oversight of method development, qualification, tech transfer, and validation for Drug Substance and Drug Product conducted at external labs and vendors.
- Coordinate Quality Events (Deviations, Investigations, CAPAs) with CMOs and escalate them to QA management.
- Collaborate with CMC and RA in the implementation of product specifications at vendors and for regulatory filings.
- Coordinate and/or perform GMP audits.
- Support the Leap QMS optimization by leading SOP development for GMP activities.
- Support the maintenance of Leap QMS and EDMS systems.
- Support QA management on compiling Quality associated metrics.
Inspection Readiness
- Participate in the review of relevant regulatory dossiers and responses to regulatory agency queries and Qualified Person (QP) queries throughout the product lifecycle.
- Serve as SME for QA operations to support all regulatory inspections.
- Provide leadership and guidance during the preparation and participation of health authorities’ inspections and support and regulatory filings.
Education / Experience / Skills:
- Bachelor’s or Master’s Degree in science, pharmacy or related discipline is required. MBA or PhD as educational background is an advantage.
- Minimum of 7-10 years’ experience in Quality Assurance/Compliance in biopharma/biologics.
- Extensive knowledge of FDA and EU GMP regulations as well as ICH guidelines.
- Demonstrated knowledge and direct experience with developing and establishing Quality Systems and GxP compliance within a regulated environment.
- Sterile manufacturing experience and knowledge of US and EU aseptic processing guidelines.
- Experience supporting and managing US, EU and/or ROW regulatory inspections.
- Experience leading internal and external audits, auditing certification preferred.
- Excellent communication and interpersonal skills for effectively interfacing with internal and external personnel at all levels.
- Excellent attention to detail and strong project management skills.
- Ability to manage multiple projects with aggressive timelines and changing priorities.
- Continuous improvement mind-set and disposition is critical.
- Provides reliable / defendable interpretations of regulatory guidance and is capable of defending these positions to regulatory agencies.
- Ability to effectively present information and respond to questions from Executive Leadership team.
Leap is an equal opportunity employer and extends equal opportunity to all individuals, without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic disposition, caregiver status, reproductive health decisions, status as a victim of domestic violence, sexual violence or stalking, credit history, criminal history, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. We are committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives.